Historical
GB/T 16886.11-1997
Biological evaluation of medical devices--Part 11: Tests for systemic toxicity (TEXT OF DOCUMENT IS IN CHINESE)
This standard provides evaluation methods for potential systemic toxicity of medical devices which release constituents into human bodies, including pyrogen test methods.
The test methods established in this standard refer to international standards, national standards, directives and regulations. The medical devices and their leaching chemicals covered in this standard should choose appropriate extraction medium and provide maximum extraction for leaching materials so as to have biological tests on extract liquid or leaching materials.
CONTENT PROVIDER
CHINESE GB Standards [spc]
CHINESE GB Standards [spc]